BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    Z5C

    FDA 510(k)
    FDA Class 2 ·Dental

    Integra®

    FDA UDI
    INTEGRA PAIN MANAGEMENT·10381780260530·MYELOGRAM TRAY

    NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·December 3, 2015

    UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    2520274-2013-02832

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 29, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 17, 2011

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015